MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Dyspnea (1816)

Event Date 06/30/2014

Event Type  Injury  

Event Description

It was reported that the adverse event was serious and that the patient did not discontinue from the study as a result.

Event Description

A serious adverse event form for a study patient was received.It was noted that the patient suffered an intermittent breathing disorder that was moderately severe.The patient was hospitalized and the device was programmed off.It was noted that the event was possibly related to implantation and stimulation.Clinic notes noted that the patient reported that the magnet was used to disable the device the night prior to hospitalization due to breathing problems.It was noted that the breathing problems improved following device deactivation.The physician advised the patient to leave the device disabled until further examination takes place.It was later reported that the vns was successfully programmed back on.Device diagnostics were within normal limits and the patient was discharged from the hospital on (b)(6) 2014.The event was resolved.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 3988716
• MDR Text Key: 4733149
• Report Number: 1644487-2014-01970
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2014
• Device Model Number: 106
• Device Lot Number: 3378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 85